HELOISE Study: A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01450696
First received: October 10, 2011
Last updated: April 2, 2016
Last verified: April 2016
  Purpose
This randomized, open-label, multicenter, international phase IIIb study will compare the efficacy and safety of two Herceptin (trastuzumab) dosing regimens in combination with cisplatin/capecitabine chemotherapy in patients with metastatic gastric or gastro-esophageal junction adenocarcinoma. Patients who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously either an 8 mg/kg loading dose followed by 6 mg/kg every 3 weeks or an 8 mg/kg loading dose followed by 10 mg/kg every 3 weeks. Capecitabine will be administered for 6 cycles at a dose of 800 mg/m2 orally twice on Days 1-14 of each 3-week cycle, cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m2 on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression occurs.

Condition Intervention Phase
Gastric Cancer
Drug: capecitabine
Drug: cisplatin
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of overall survival in patients with trastuzumab minimum concentrations Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Trastuzumab minimum concentrations (Cmin) on Day 21 of Cycles 1-11 [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Progression-free survival in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Objective response rate in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]

Enrollment: 296
Study Start Date: December 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: capecitabine
1600 mg/m2 orally daily Days 1-14 of each 3-week cycle, 6 cycles
Drug: cisplatin
80 mg/m2 iv on Day 1 of each 3-week cycle, 6 cycles
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 6 mg/kg iv every 3 weeks
Experimental: B Drug: capecitabine
1600 mg/m2 orally daily Days 1-14 of each 3-week cycle, 6 cycles
Drug: cisplatin
80 mg/m2 iv on Day 1 of each 3-week cycle, 6 cycles
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 10 mg/kg iv every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least liver or lung or both
  • Measurable disease according to RECIST 1.1 or non-measurable evaluable disease
  • At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor. Metastasis in distant lymph nodes, peritoneal metastasis, malignant pleural effusion, etc. count as 'organs' in this context
  • HER2-positive primary or metastatic tumor
  • Adequate renal function (Creatinine clearance >/= 45 mL/min)
  • Eastern Cooperative Oncology Group (ECOG) performance status 2

Exclusion Criteria:

  • Previous chemotherapy for locally advanced or metastatic disease
  • Prior gastrectomy (partial or total) for the underlying malignant disease under investigation
  • Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
  • Residual relevant toxicity resulting from previous therapy
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with a jejunostomy probe, gastric or jejunostomy tubes which may impair the ability to administer or absorb capecitabine)
  • Current gastrointestinal bleeding
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin
  • History of documented congestive heart failure; angina pectoris requiring medication; electrocardiogram (ECG) evidence of trans-mural myocardial infraction; poorly controlled hypertension; clinically significant valvular heart disease; or high risk uncontrollable arrhythmias
  • Baseline LVEF <50%, documented by echocardiography, MUGA scan, or cardiac MRI
  • Chronic high-dose corticosteroid therapy
  • History or clinical evidence of brain metastases
  • Pregnant women
  • Active infection with HIV, hepatitis B, hepatitis C, or HIV-positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450696

  Hide Study Locations
Locations
United States, California
La Jolla, California, United States, 92093
Los Angeles, California, United States, 90033
Whittier, California, United States, 90603
Whittier, California, United States, 90606
United States, Indiana
Goshen, Indiana, United States, 46526
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, New York
New York, New York, United States, 10065
United States, Oregon
Portland, Oregon, United States, 97239
United States, South Carolina
Charleston, South Carolina, United States, 29425
Australia, New South Wales
Port Macquarie, New South Wales, Australia, 2444
Wahroonga, New South Wales, Australia, 2076
Australia, South Australia
Woodville South, South Australia, Australia, 5011
Australia, Western Australia
Murdoch, Western Australia, Australia, 6150
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajewo, Bosnia and Herzegovina, 71000
Brazil
Rio de Janeiro, RJ, Brazil, 20560-120
Porto Alegre, RS, Brazil, 90610-000
Barretos, SP, Brazil, 14784-400
Sao Paulo, SP, Brazil, 01246-000
Sorocaba, SP, Brazil, 18030-245
Chile
Santiago, Chile, 7500921
Santiago, Chile, 8380456
Viña del Mar, Chile, 2520612
China
Beijing, China, 100853
Beijing, China, 100050
Beijing, China, 100071
Beijing, China, 100142
Changchun, China, 130012
Changsha, China, 410006
Changzhou, China, 213003
Guangzhou, China, 510060
Hangzhou, China, 310016
Nanjing, China
Shanghai, China, 200032
Wuhan, China, 430030
Zhengzhou, China, 450008
Czech Republic
Brno, Czech Republic, 656 53
Olomouc, Czech Republic, 775 20
Praha 2, Czech Republic, 128 08
Praha 8, Czech Republic, 180 81
Germany
Berlin, Germany, 10117
Frankfurt, Germany, 60488
Mannheim, Germany, 68167
Hungary
Budapest, Hungary, 1097
Budapest, Hungary, 1145
Pecs, Hungary, 7623
Szolnok, Hungary, 5004
Szombathely, Hungary, 9700
Veszprem, Hungary, 8200
Italy
Catanzaro, Calabria, Italy, 88100
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Reggio Emilia, Emilia-Romagna, Italy, 42100
Udine, Friuli-Venezia Giulia, Italy, 33100
Milano, Lombardia, Italy, 20133
Ancona, Marche, Italy, 60121
Florence, Toscana, Italy, 50124
Pisa, Toscana, Italy, 56100
Korea, Republic of
Bundang City, Korea, Republic of, 463-802
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 03722
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 130-872
Seoul, Korea, Republic of, 135-720
Mexico
Distrito Federal, Mexico, 14080
Mexico City, Mexico, 06760
Monterrey, Mexico, 64020
Oaxaca, Mexico, 68000
New Zealand
Auckland, New Zealand, 1023
Panama
Panama, Panama, 0834-02723
Peru
Arequipa, Peru, 04001
Arequipa, Peru, 5154
Lima, Peru, 1
Lima, Peru, 34
Lima, Peru, Lima 1
Lima, Peru, Lima 41
Trujillo, Peru, 13011
Philippines
Manila, Philippines, 1000
Pasig City, Philippines, 1605
Poland
Krakow, Poland, 31-501
Lublin, Poland, 20-090
Warsaw, Poland, 00-973
Wieliszew, Poland, 05-135
Portugal
Porto, Portugal, 4200-072
Russian Federation
Ivanovo, Russian Federation, 153040
Omsk, Russian Federation, 644013
Ryazan, Russian Federation, 390011
St Petersburg, Russian Federation
Stavropol, Russian Federation, 355045
Tula, Russian Federation, 300053
Serbia
Belgrade, Serbia, 11000
Nis, Serbia, 18000
Sremska Kamenica, Serbia, 21204
South Africa
Bloemfontein, South Africa, 9300
Cape Town, South Africa, 7506
Johannesburg, South Africa, 2193
Spain
Barcelona, Spain, 08035
Barcelona, Spain, 08041
Madrid, Spain, 28046
Turkey
Adana, Turkey, 01250
Gaziantep, Turkey, 27100
Istanbul, Turkey, 34890
Izmir, Turkey, 35100
Izmir, Turkey, 35340
Malatya, Turkey, 44280
Sıhhiye, ANKARA, Turkey, 06100
Ukraine
Cherkassy, Ukraine, 18009
Chernivtsi, Ukraine, 58013
Dnipropetrovsk, Ukraine, 49102
Donetsk, Ukraine, 83092
Kiev, Ukraine, 03115
Lvov, Ukraine, 79031
United Kingdom
Denbighshire, United Kingdom, LL185UJ
Leicester, United Kingdom, LE1 5WW
Southampton, United Kingdom, SO16 6YD
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01450696     History of Changes
Other Study ID Numbers: BO27798  2011-001526-19 
Study First Received: October 10, 2011
Last Updated: April 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Capecitabine
Trastuzumab
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016